Distinguished Scientist, Companion Diagnostics

Job Description The Distinguished Scientist/ Executive Director within Companion Diagnostics (CDx) Development will lead one of our Diagnostic Development Teams (DxDTs) and supervise PhD/MD level employees. The role oversees CDx strategy development, alignment, and execution for specific projects, including digital pathology (DP) projects when applicable. The position reports to the Associate Vice President, Companion Diagnostics (CDx). Primary Responsibilities Lead a cross‑functional DxDT including Regulatory, Commercial, Business Development, Project Management, Operations, Clinical Development, Statistics, Bioinformatics, etc. to drive CDx strategy, development, and implementation for a portfolio of various assets/biomarkers, primarily in oncology. Supervise PhD/MD level employees and coordinate work with external Dx partners, including DP efforts when needed. Partner with internal stakeholders (clinical/asset teams, Biomarker Leads, CDx Regulatory, Commercial) to assess DxDT needs and develop strategies. Contribute to the selection of assays, platforms, and Dx partners and oversee pilot study design/execution with vendors. Identify and assess novel technologies/platforms with potential CDx application. Oversee regulatory document preparation (pre‑submissions, briefing books, IDEs, IVDR PSAs, PMAs) and participation in meetings with global regulatory agencies. Manage operational tasks such as ordering samples, QC of clinical trial biomarker results, assay/data transfer troubleshooting, etc. Serve as a subject‑matter expert across project teams, biomarkers, clinical operations, regulatory affairs, medical affairs, and commercial on implementing global CDx assay strategies in trials. Oversee internal project‑level senior management and governance interactions relevant to CDx. Provide input into preclinical and early‑stage oncology programs. Provide CDx expertise and assessment for due diligence teams. Education Minimum Requirements PhD Required Experience and Skills Minimum of 8 years of experience in an industry setting. Extensive experience with one or more major biomarker platforms (NGS, IHC, PCR). Knowledge of discovery, development, and application of biomarkers in drug development and as CDx. Demonstrated track record in the development and approval of CDx. Demonstrated expertise in diagnostic development evidenced by peer‑review publication record, patents, and/or products. Experience developing and implementing strategic approaches across functional groups and with global pharma teams. Experience working with clinical teams to support design, implementation, and analysis of clinical trials incorporating key biomarkers to support CDx development and regulatory submissions. Familiarity with EU IVDR, China HGRAC, Japan PMDA, and other global markets requirements for CDx development/registration. Proven decision‑making and planning skills. High level of verbal and written communication skills, including presentation capabilities to senior executives. Preferred Experience and Skills Experience in both pharma and Dx settings. Deep technical knowledge in an area such as circulating tumor DNA (ctDNA), immunohistochemistry/pathology, digital pathology, etc. Direct experience interfacing in meetings and with written documents with global health authorities. Required Skills Analytical Thinking Assay Bioanalytical Techniques Biomarker Development Clinical Trials Communication Companion Diagnostics (CDx) Drug Development Innovation Leadership Scientific Leadership Strategic Foresight Preferred Skills None Salary and Benefits Salary range: $210,400.00 – $331,100.00. Annual bonus and long‑term incentive, if applicable. Comprehensive benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days. More information: Employment Details Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st – Day Valid Driving License: No Hazardous Material(s): n/a EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information: EEOC Know Your Rights, EEOC GINA Supplement, and state‑level acts. Location US and Puerto Rico Residents Only. If located in San Francisco or Los Angeles, we will consider qualified applicants in compliance with local fair‑chance ordinances. Job Posting End Date 07/1/2026 #J-18808-Ljbffr Merck & Co.